Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03835676
• Date of registration: 06/02/2019
• Prospective Registration: Yes
• Primary sponsor: Magdi H. Yacoub
• Public title: Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension
• Scientific title: Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: May 1, 2019
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03835676
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Magdi H Yacoub, OM FRS
• Affiliation: Magdi Yacoub Heart Foundation - Aswan Heart Centre

• Name: Ahmed M ElGuindy, MD, MRCP

• Name: Ahmed M ElGuindy, MD, MRCP

Key inclusion & exclusion criteria

- Inclusion Criteria:

- PAH defined as a mean pulmonary artery pressure >25 mmHg on right heart
catheterization at rest in the setting of a normal pulmonary arterial wedge
pressure =15 mm Hg

- PAH that is idiopathic, familial, or associated with connective tissue disease.

- WHO class III or class IV despite the use of Endothelin receptor antagonists
(ERA) and/or phosphodiesterase-5 inhibitors

- Age > 18 years

- Sinus rhythm

- Exclusion Criteria:

- Patients with PAH associated with HIV infection, portal hypertension, congenital
heart disease, schistosomiasis, chronic haemolytic anaemia

- Patients with pulmonary hypertension due to veno-occlusive disease and/or
pulmonarycapillary haemangiomatosis, thromboembolism.

- Patients with left side heart disease that may contribute to pulmonary
hypertension. Those patients are identified by having pulmonary wedge pressure
>15 mmHg or elevated Left Ventricle (LV) end-diastolic pressure

- Patients who are severely disabled and will not be able to complete the study

- Patients with significant lung disease as shown by forced vital capacity (FVC) <
70% predicted, or forced expiratory volume at one second (FEV1)/FVC < 50% - Life
expectancy <1 year due to severe PAH or any other forms of terminal disease.

- Pregnant women

- Refusal to give informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Treprostinil

Primary Outcome(s)

Assessment of Treprostinil effects on right ventricular structure and function using Cardiac Magnetic Resonance Imaging (CMR). [Time Frame: through study completion, an average of 5 years]

Assessment of Treprostinil effects on right ventricular structure and function using echocardiography [Time Frame: through study completion, an average of 5 years]

Secondary Outcome(s)

Correlate changes in RV structure and function with prespecified biomarkers [Time Frame: through study completion, an average of 5 years]

Correlate changes in RV structure and function with the Six-minute walk test results [Time Frame: through study completion, an average of 5 years]

Correlate changes in RV structure and function with QoL [Time Frame: through study completion, an average of 5 years]

Correlate changes in RV structure and function with World Health Organisation (WHO) Class. [Time Frame: through study completion, an average of 5 years]

Secondary ID(s)

Treprostinil RV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors